With eight more cases preparing for trial, can 3M keep winning?
Or is Bair Hugger destined to be on the trash heap of former medical products?
With over 4,500 lawsuits filed by patients, things are certainly “heating” up for its manufacturer, 3M. This forced-air warming system is designed to prevent hypothermia and helps patients maintain normal core temperature throughout surgical phases. It is comprised of a central warming unit that sends warm air through a hose into a disposable blanket, which is draped around or under the patient. The blanket also has drain holes where excess fluids can pass through onto a linen underneath.
3M says that warming blanket system helps avoid a “cascade of negative outcomes associated with unintended hypothermia, including increased risk of SSIs (surgical site infections), blood loss and transfusion requirements, adverse cardiac events, decreased drug metabolism, and shivering and thermal discomfort” to patients.
The FDA cleared the first Bair Hugger warming system in 1987 and has issued numerous clearances for it since. The Bair Hugger is used in 4 out of 5 hospitals and on over 200 million patients across the globe. But despite its popularity, legal problems are caving in on Bair Hugger blanket.
One of the first patients who filed a lawsuit in 2011 sought more than $1 million in damages against 3M after he developed an infection following his hip replacement surgery, which required 15 follow up operations.
Another individual developed a MRSA (Methicillin-resistant Staphylococcus aureus) infection after her knee replacement surgery and needed 27 additional operations. Another required leg amputation after multiple unsuccessful revision surgeries to treat an infection formed after a total knee arthroplasty. The list continues on.
Every patient suing 3M had serious complications or infections following surgeries that involved the Bair Hugger blanket.
But, as we just saw in the May 2018 case in Minneapolis, Minnesota, juries may have hard time believing that Bair Hugger is unreasonably dangerous AND that a reasonably safe alternative exists.
The Plaintiff’s Case
Attorneys for the injured patients argue scientific research shows the device can spread airborne contaminants while used on surgical patients. Dr. Scott D. Augustine, the inventor of the Bair Hugger system, even testified against the product, claiming that the warming unit can substantially disrupt the flow of sterile air inside an operating room. However, 3M maintained its product actually prevents infections and provides better surgical outcomes for patients. Despite the ensuing litigation, 3M consistently reassured the public that the Bair Hugger is safe and effective.
Hospital systems and doctors are often included as defendants in the Bair Hugger lawsuits. Patients are typically unaware what led to their injury, so they name all entities involved as responsible parties. After the complaint survives the initial technical and court procedural stages, it moves forward to the discovery process, which allows the parties to dig up all relevant facts to the case. Attorneys interview doctors and support staff in depositions regarding the diagnoses, treatment, procedures, and other actions they took related to the patient. This helps establish whether medical professionals engaged in any deviant behavior or misuse of medical products or services on the injured patients.
However, if appropriate protocols were followed, the spotlight turns on product malfunctions. Different parties can be legally responsible for defective products. The designer of a product may be held responsible if the product is defectively designed. The manufacturer of the product may be responsible if the product is defectively manufactured. And the maker, manufacturer, and seller of a product may all be responsible if a defective warning fails to inform the consumer of the product’s risks.
